About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS. 

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way. 

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history. We all share the most important goal of bringing solutions to the PWS community. 

Summary of Job (brief description)

The Clinical Trial Manager (CTM)/Senior CTM reports to the Vice President, Clinical Operations and is responsible for the end-to-end operational leadership and execution of Soleno’s clinical programs across all phases of development, including post-marketing, observational, and global studies.

This role provides cross-functional leadership and vendor oversight to ensure trials are delivered on time, within budget, and in compliance with protocols, SOPs, ICH GCP, and applicable global regulatory requirements. The CTM partners closely with internal stakeholders and external vendors to proactively manage risk, ensure inspection readiness, and drive operational excellence in support of Soleno’s approved products and lifecycle development programs.

This role requires adaptability and willingness to travel domestically and internationally as needed to support trial execution.

Responsibilities

Study Execution & Leadership

• Leads operational planning and execution of assigned clinical trials from start-up through close-out
• Contributes to protocol development and review to ensure operational feasibility, site practicality, and compliance with regulatory requirements
• Develops and manages timelines, budgets, and resources
• Drives cross-functional alignment with Clinical Development, Regulatory, Pharmacovigilance, Data Management, QA, and CMC
• Ensures inspection readiness and high-quality trial conduct across all phases

Service Provider & CRO Oversight

• Leads CRO and service provider selection and scope development
• Oversees service provider performance through governance, KPIs, and regular reviews
• Ensures appropriate sponsor oversight and compliance with contracted services
• Reviews and approves budgets, change orders, and invoices

Site & Monitoring Oversight

• Oversees site feasibility, selection, activation, and recruitment strategy
• Provides oversight of monitoring activities and data quality
• Reviews monitoring reports and addresses performance or compliance issues
• Ensures timely resolution of protocol deviations, GCP issues, and CAPAs

Trial Management & Compliance

• Develops and reviews informed consents, feasibility assessments, study plans, manuals, and operational documents
• Reviews and provides operational input on case report forms (CRFs), CRF completion guidelines, edit check specifications, and other data management documents to ensure data quality, feasibility, and alignment with protocol objectives
• Participates in user acceptance testing (UAT) and validation of EDC and other clinical systems to ensure functionality supports study execution and data integrity
• Ensures TMF completeness and quality
• Oversees investigational product accountability
• Implements risk-based quality management practices
• Supports audits and regulatory inspections

Financial & Operational Management

• Manages study budgets, accruals, and forecasts
• Reviews and approves investigator clinical trial agreements and site payments
• Tracks study metrics and provides updates to leadership
• Identifies risks and implements mitigation strategies

Regulatory & Clinical Reporting

• Partners with Clinical Development, Biostatistics, and Medical Writing on clinical study report (CSR) planning, content review, and finalization
• Provides operational input and documentation to support regulatory submissions (e.g., NDA/MAA supplements, annual reports, post-marketing commitments, safety updates)
• Ensures inspection-ready documentation and timely responses to regulatory inquiries
• Supports health authority inspections and audits as a clinical operations representative

Process Improvement & Leadership

• Contributes to SOP development and continuous process improvements
• Mentors and guides CTAs/CRAs and other team members

• May manage clinical operations staff and contribute to yearly evaluations, provide development opportunities and address any performance issues identified
• Supports departmental initiatives and best practices
• Performs other duties as assigned.

Qualifications

• Bachelor’s degree in life sciences or related field required
• 6 – 8+ years of related clinical trial management experience
• Demonstrated experience with the unique operational and regulatory considerations of all phases, including post-marketing trials
• Rare Disease experience strongly preferred
• Experience in managing outside service providers (e.g., CROs, central laboratories, and other vendors)
• Strong knowledge of FDA, EMA, global regulatory requirements and ICH GCP
• Experience with risk-based quality management and inspection readiness
• Proven ability to manage budget and timelines
• Strong leadership, communication, and problem-solving skills to drive results that are needed to achieve company objectives
• Ability to travel domestically and internationally as required

Salary Range: $145,000 - $185,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)